A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease
This study has been completed.
Sponsor:
Baxter Healthcare Corporation
Collaborator:
Alzheimer's Disease Cooperative Study (ADCS)
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00818662
First received: January 7, 2009
Last updated: March 18, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to determine whether IGIV, 10% treatment, administered at two different doses for 18 months, slows the rate or prevents the progression of dementia symptoms in subjects with mild to moderate Alzheimer´s Disease (AD). Subjects will be randomly assigned to receive intravenous infusions of either of two doses of IGIV, 10% or placebo every two weeks for 70 weeks (36 infusions) as an add-on to conventional Food and Drug Administration (FDA)-approved AD medications.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer´s Disease |
Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Other: Placebo solution |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Two Dose Arm, Parallel Study of the Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease |
Resource links provided by NLM:
Further study details as provided by Baxter Healthcare Corporation:
Primary Outcome Measures:
- Cognition and global function [ Time Frame: 18 months ] [ Designated as safety issue: No ]Measured by the cognitive subscale of the Alzheime´s Disease Assessment Scale (ADAS-Cog) and the Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL)
Secondary Outcome Measures:
- Cognition and global function [ Time Frame: 9 months ] [ Designated as safety issue: No ]Measured by ADAS-Cog and ADCS-ADL
| Enrollment: | 390 |
| Study Start Date: | December 2008 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
|
Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
400 mg/kg bodyweight every 2 weeks for 70 weeks
Other Name: Gammagard Liquid
|
|
Experimental: Group 2
Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
|
Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
200 mg/kg bodyweight every 2 weeks for 70 weeks
Other Name: Gammagard Liquid
|
| Placebo Comparator: Group 3 |
Other: Placebo solution
4 or 2 mL/kg bodyweight every 2 weeks for 70 weeks
|
Detailed Description:
Study visits: Each subject will be tested at the investigational site, and if qualified, will be treated intravenously (through a vein) every two weeks for 70 weeks (approximately 18 months). The first three infusions must be done at the site, but if the infusions are well tolerated, subsequent infusions may be done by a qualified healthcare provider in the home or other suitable location. Each subject must return to the site every 3 months for evaluation of cognition as well as blood tests and scans of the brain.
Eligibility| Ages Eligible for Study: | 50 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Written informed consent - subject (or subject´s legally acceptable representative) and caregiver who are willing and able to participate for the duration of the study
- Diagnosis of probable Alzheimer´s Disease (AD)
- Dementia of mild to moderate severity defined as mini-mental state examination (MMSE) 16-26 inclusive at the time of screening
- Neuroimaging (computed tomography [CT] or MRI) performed after symptom onset consistent with AD diagnosis
- Ability to comply with testing and infusion regimen, including fluency in English or Spanish, adequate corrected visual acuity and hearing ability
- On stable doses of FDA approved AD medication(s) for at least 3 months prior to screening. These medications must be continued throughout this study.
- If receiving psychoactive medications (e.g. antidepressants other than monoamine oxidase inhibitors (MAOIs) and most tricyclics, antipsychotics, anxiolytics, anticonvulsants, mood stabilizers, etc), must be on stable doses for at least 6 weeks prior to screening
Exclusion Criteria (Reasons why it might not be appropriate to participate):
- Any other forms of dementia
Medical issues that might increase the risk of treatment with IGIV, 10%, such as:
- Significant problems with blood pressure, heart disease, clotting disorders, strokes or recent heart attacks
- Evidence of current bleeding in the brain by MRI
- Serious problems with the liver or kidneys
- Allergies to blood products
Medical issues that might interfere with the evaluation of the treatment of dementia or might make dementia worse, such as:
- Diabetes
- Recent treatment with chemotherapy or immune suppression
- The recent use of other investigational drugs, especially antibody therapy for AD
- Severe headaches or psychiatric problems
There are other reasons why it might not be appropriate to participate in this trial. Please consult an investigator at one of the trial sites for details.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818662
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Hide Study LocationsLocations
| United States, Alabama | |
| University of Alabama, Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Banner Alzheimer´s Institute | |
| Phoenix, Arizona, United States, 85006 | |
| Banner Sun Health Research Institute | |
| Sun City, Arizona, United States, 85351 | |
| University of Arizona | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| University of California | |
| Irvine, California, United States, 92697 | |
| University of California, San Diego, Department of Neurosciences | |
| La Jolla, California, United States, 92093 | |
| University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| Synergy Clinical Research Center | |
| National City, California, United States, 91950 | |
| University of California, Irvine | |
| Orange, California, United States, 92868 | |
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
| United States, District of Columbia | |
| Howard University | |
| Washington, District of Columbia, United States, 20060 | |
| Georgetown University | |
| Washington, District of Columbia, United States, 20057 | |
| United States, Florida | |
| Wien Center for Clinical Research | |
| Miami Beach, Florida, United States, 33140 | |
| Roskamp Institute | |
| Sarasota, Florida, United States, 34243 | |
| University of South Florida / Suncoast | |
| Tampa, Florida, United States, 33613 | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| University of Kansas | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Massachusetts | |
| Lahey Clinic, Inc. | |
| Burlington, Massachusetts, United States, 01805 | |
| United States, Michigan | |
| Bronson Lake View Psychiatry | |
| Paw Paw, Michigan, United States, 49079 | |
| United States, Minnesota | |
| Mayo Clinic, Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| St. Louis University | |
| St. Louis, Missouri, United States, 63104 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-5580 | |
| United States, Nevada | |
| Cleveland Clinic Lou Ruvo Center for Brain Health | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New York | |
| Neurological Care of CNY | |
| Liverpool, New York, United States, 13088 | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| The Weill Cornell Memory Disorders Program (Cornell University) | |
| New York, New York, United States, 10021 | |
| New York University Medical Center | |
| New York, New York, United States, 10016 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14620 | |
| United States, Ohio | |
| University Hospitals Case Medical Center | |
| Beachwood, Ohio, United States, 44122 | |
| United States, Oklahoma | |
| Tulsa Clinical Research | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| N. Charleston, South Carolina, United States, 29406-6076 | |
| United States, Tennessee | |
| Psychiatric Consultants | |
| Franklin, Tennessee, United States, 37067 | |
| United States, Texas | |
| University of Texas, Southwestern Medical Center | |
| Dallas, Texas, United States, 75390-9070 | |
| United States, Utah | |
| University of Utah Center for Alzheimer´s Care, Imaging and Research | |
| Salt Lake City, Utah, United States, 84108 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53705 | |
| Canada, British Columbia | |
| University of British Columbia | |
| Vancouver, British Columbia, Canada, V6T 2B5 | |
| Canada, Ontario | |
| Parkwood Hospital | |
| London, Ontario, Canada, N6C 5J1 | |
| Toronto Memory Program | |
| Toronto, Ontario, Canada, M3B 2S7 | |
| Canada, Quebec | |
| Jewish General Hospital | |
| Montreal, Quebec, Canada, H3T 1E2 | |
Sponsors and Collaborators
Baxter Healthcare Corporation
Alzheimer's Disease Cooperative Study (ADCS)
Investigators
| Study Director: | Norman Relkin, MD, PhD | Alzheimer's Disease Cooperative Study (ADCS) |
| Study Director: | David Gelmont, MD | Baxter Healthcare Corporation |
More Information
No publications provided
| Responsible Party: | Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT00818662 History of Changes |
| Other Study ID Numbers: | 160701 |
| Study First Received: | January 7, 2009 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Baxter Healthcare Corporation:
|
Alzheimer´s Dementia Dementia of Alzheimer Type Immunoglobulins Gammaglobulins |
IVIG Antibodies Amyloid Immunotherapy |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Antibodies Immunoglobulins Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013